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Measuring G Protein-coupled Receptor Kinase-2 (GRK2) in the Blood to Diagnose and Treat Patients With Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00419965
First received: January 8, 2007
Last updated: August 18, 2010
Last verified: August 2010

January 8, 2007
August 18, 2010
October 2006
May 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00419965 on ClinicalTrials.gov Archive Site
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Measuring G Protein-coupled Receptor Kinase-2 (GRK2) in the Blood to Diagnose and Treat Patients With Heart Failure
Measuring GRK2 in the Blood to Diagnose and Treat Patients With Heart Failure

The primary objective of this study is to determine the utility of GRK2 to differentiate between normal patients and patient groups that differ by the presence/absence of HF symptoms, systolic or diastolic left ventricular dysfunction, and risk factors; and to evaluate if a new assay provides similar values as traditional methods for measuring GRK2 levels.

This study seeks to define a beta-adrenergic receptor kinase molecule in the blood and its role as an improved biomarker to be used for the diagnosis, assessment and management of patients with heart failure. We will test blood cell samples for the levels of this molecule, called "G protein-coupled receptor kinase-2" (GRK2) using both the existing method of GRK2 quantification in the Koch laboratory and using a prototype enzyme immunoassay (EIA) method being developed by Johnson & Johnson, Ortho-Clinical Diagnostics (OCD).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Frozen serum/plasma - coded samples

Probability Sample

The study population subjects includes individuals in a range of age groups with a diagnosis of heart failure or at least one cardiovascular risk factor along with a subset of normal control subjects.

Heart Failure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
582
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Normal Controls: Individuals without HF, hypertension, diabetes, hyperlipidemia, coronary artery disease or obesity;
  • Group I: Symptomatic Subjects with Reduced LV Function, HF symptoms, EF ≤ 40%.
  • Group II: Asymptomatic Patients with LV dysfunction, no HF symptoms (NYHA class I and ATS score 0 or 1, EF ≤ 40%.
  • Group III: Symptomatic Subjects with Preserved LV Function, HF symptoms, EF ≥ 50%, and diastolic dysfunction.
  • Group IV: Asymptomatic High Risk Subjects - Individuals with normal heart function, no HF symptoms (NYHA class I and ATS score 0 or 1), Preserved LV function (EF ≥ 50%), no diastolic dysfunction. Also possess one or more cardiovascular high risk factors: diagnosis of diabetes; hyperlipidemia; coronary artery disease; renal insufficiency; hypertension; age >70 years

Exclusion Criteria

  • Pregnancy
  • Not providing consent
  • Inability to provide consent
  • Participation in a clinical study involving an experimental therapy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00419965
06C.358
Yes
Walter J. Koch PhD (PI), Thomas Jefferson University Office of Research Administration
Thomas Jefferson University
Johnson & Johnson
Principal Investigator: Walter J. Koch, PhD Thomas Jefferson University
Thomas Jefferson University
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP